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Transient Thermal Behavior and Diabetic Foot (PICOTE)

Primary Purpose

Diabetic Patients Type 1 and 2, Podologic Grade From 0 to 3

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Infrared Thermography
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Patients Type 1 and 2 focused on measuring Infrared Thermography, Diabetic foot, Six minutes walking test, Microcirculation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetic subjects (type 1 and 2)
  • age above 18 years old
  • able to walk
  • affiliate to insurance regimen

Exclusion Criteria:

  • unable to stay motionless
  • pregnancy
  • subjects with feet wound

Sites / Locations

  • CHU Montpellier - Lapeyronie hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study participants

Arm Description

Measurements of the temperature of the plantar arch by thermal imaging. Result analysis regarding podologic grade ( 0-1-2-3)

Outcomes

Primary Outcome Measures

Thermal signals measured on plantar foot
Determine the transient thermal responses at the plantar foot
Correlation with podologic grade
The classification of foot risk, mentioned in 2007 in the HAS report, is as follows ([HAS 2007]) Diabetic Foot Report http://www.has-sante.fr/portail/upload/docs/application/pdf/_foot_diabetic.pdf, 2007 : Grade 0: absence of sensitive neuropathy Grade 1: isolated sensitive neuropathy Grade 2: sensitive neuropathy associated with arteriopathy of the lower limbs and/or foot deformities Grade 3: history(s) of foot ulceration (grade3a) and/or lower limb amputation (grade 3b)

Secondary Outcome Measures

Full Information

First Posted
February 22, 2019
Last Updated
December 9, 2021
Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03872089
Brief Title
Transient Thermal Behavior and Diabetic Foot
Acronym
PICOTE
Official Title
Transient Thermal Behavior and Diabetic Foot
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Inclusion of the last patient
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
April 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In our study, the investigators propose to analyze the transient thermal responses taken at the level of the sole of the foot, following the application of a cold stimulus. By combining a spatio-temporal analysis of these temperature fields and a thermal modeling of the heat transfer in the thickness of the foot, the investigators want to highlight differences between healthy feet vs. pathological feet. Therefore, the investigators will determine the transient thermal responses at the level of the sole of the foot and correlate them with the podological grade.
Detailed Description
Both plants of the patient's feet will be observed by a thermal camera. Static observations (taking a single image), or dynamic (taking a series of images) of the foot, will be made. In the latter case, the observation will be done after a brisk walk of 6 min. The instruction given to patients will be to go the furthest in 3 min and then come back in 3 min, all while walking. The observation will be made by cameras without contact. These thermal cameras are non-invasive and non-ionizing, there is no risk related to their use. The camera will be placed on a tripod, a few tens of centimeters from the foot, and connected to a laptop (for the images acquisition). A wooden box, painted black, will be placed around both feet to protect the scene from parasitic thermal radiation that can disturb temperature variations. Foam will protect the skin / wood interface. Electric resistances, fixed on the box, will be placed in the field of vision of the thermal camera to guarantee the good treatment of the images. These resistors will never be in contact with the patient. The area filmed by the camera will be limited to the sole arch and, sometimes, the hand of patients to see if a thermal anomaly is also present on this member.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Patients Type 1 and 2, Podologic Grade From 0 to 3
Keywords
Infrared Thermography, Diabetic foot, Six minutes walking test, Microcirculation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study participants
Arm Type
Experimental
Arm Description
Measurements of the temperature of the plantar arch by thermal imaging. Result analysis regarding podologic grade ( 0-1-2-3)
Intervention Type
Other
Intervention Name(s)
Infrared Thermography
Intervention Description
Measurements of the temperature of the plantar arch by thermal imaging (Infrared Thermography)
Primary Outcome Measure Information:
Title
Thermal signals measured on plantar foot
Description
Determine the transient thermal responses at the plantar foot
Time Frame
At the inclusion
Title
Correlation with podologic grade
Description
The classification of foot risk, mentioned in 2007 in the HAS report, is as follows ([HAS 2007]) Diabetic Foot Report http://www.has-sante.fr/portail/upload/docs/application/pdf/_foot_diabetic.pdf, 2007 : Grade 0: absence of sensitive neuropathy Grade 1: isolated sensitive neuropathy Grade 2: sensitive neuropathy associated with arteriopathy of the lower limbs and/or foot deformities Grade 3: history(s) of foot ulceration (grade3a) and/or lower limb amputation (grade 3b)
Time Frame
At the inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetic subjects (type 1 and 2) age above 18 years old able to walk affiliate to insurance regimen Exclusion Criteria: unable to stay motionless pregnancy subjects with feet wound
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariane Sultan, MD-PhD
Organizational Affiliation
Equipe Nutrition Diabete- CHU Lapeyronie- Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Montpellier - Lapeyronie hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transient Thermal Behavior and Diabetic Foot

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